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The Accell Family of products are intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The products are indicated for use as bone graft extenders in the spine, extremities and pelvis, or as bone void fillers in the extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.

Accell DBM family of products are used for orthopaedic bone grafting procedures. They are osteoconductive human allogenic demineralized bone filling materials for use as fillers for gaps or voids that are not intrinsic to the stability of the bony structure. Accell DBM family of products are products that are manufactured using human donor demineralized bone and may contain up to 70% poloxamer reverse phase medium carrier (RPM). The demineralized bone is derived from human ground, cortical allograft bone. Poloxamer RPM is an inactive product ingredient that is utilized as a containing agent for the demineralized bone and provides appropriate product handling characteristics for the products. The products of the Accell DBM family are comprised of the same DBM and RPM components as found in DynaGraft II Gel, FDA cleared under 510(k) number K040419 and Connexus cleared under 510(k)'s K050690 and K052098. In addition, the Accell DBM family of products may contain up to a maximum of 70% of RPM carrier. This is the concentration of RPM already cleared in DynaGraft II gel.

OrthoBlast® It DBM Paste and Putty are bone filling materials indicated for augmentation or reconstructive treatment of alveolar ridge. This includes: - Filling of defects after root resection, apicoectomy and cystectomy ・ - Filling of extraction sockets to enhance preservation of the alveolar ridge - - Elevation of maxillary sinus floor -

OrthoBlast® II DBM Paste and Putty is derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a reverse phase carrier, cancellous chips from the same donor, and then formulated to a paste or puttylike consistency. OrthoBlast® II DBM Paste and Putty are osteoconductive and osteoinductive bone filling material. The osteoinductive potential is demonstrated in athymic mouse model.

Accell Connexus™ DBM Putty is a bone filling material indicated for augmentation or reconstructive treatment of alveolar ridge. This includes: - Filling of defects after root resection, apicoectomy and cystectomy - - Filling of extraction sockets to enhance preservation of the alveolar ridge - - Elevation of maxillary sinus floor - - Treatment of periodontal defects -

Accell Connexus™ DBM Putty is derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a reverse phase carrier and formulated to a paste or putty-like consistency. Accell Connexus DBM Putty is osteoconductive and osteoinductive bone filling material. The osteoinductive potential is demonstrated in athymic mouse model.

OsSatura™ Dental is a bone filling augmentation material for used for augmentation or reconstructive treatment of alveolar ridge. This includes, filling of defects after root resection, apicoectomy and cystectomy, filling of extraction sockets to enhance preservation of the alveolar ridge and elevation of maxillary sinus floor.

OsSatura™ Dental is a synthetic, osteoconductive bone void filler, which consists of a biphasic ceramic (e.g., hydroxyapatite/tri-calcium phosphate) scaffold. The interconnected and open porous structure of OsSatura™ Dental is similar in structure to human cancellous bone. OsSatura™ Dental is available as irregular shaped chips of size 1 - 2 mm.

The Open Bore Syringe is intended for use as a piston syringe for delivery of allograft, autograft or synthetic bone graft materials to an orthopedic surgical site. In addition it is designed to facilitate premixing of bone graft materials with autologous blood, plasma, platelet rich plasma, bone marrow aspirate as deemed necessary by the clinical use requirements.

The Open Bore Syringe is a standard piston syringe. It consists of a syringe barrel, piston and plunger. The distal end of the barrel is threaded to enable connection to three different adapters while without an attachment, the open end allows for filling of the bone graft material. Three distinct tips enable connection to a standard female Luer or dispensing through a tapered nozzle or extended tapered nozzle, and can be used depending on the viscosity of the bone graft material. A cap is available to seal the end of the barrel, enclosing the syringe contents. The piston/plunger assembly is used to expel from, or facilitate collection into the barrel.

OsSatura™ BCP (Biphasic Calcium Phosphate) is bone void filler intended only for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. OsSatura™ BCP is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e., extremities, spine, and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

OsSatura™ BCP is a synthetic, osteoconductive bone void filler, which consists of a biphasic ceramic (e.g., hydroxyapatite/tri-calcium phosphate) scaffold. The interconnected and open porous structure of OsSatura™ BCP is similar in structure to human cancellous bone. OsSatura™ BCP is available as irregular-shaped chips of different sizes.

SynPlug™ is a cylindrical plug intended for intramedullary occlusion during cemented hip and shoulder arthroplasty.

The proposed SynPlug™ cement restrictor is identical in intended use and fundamental scientific technology to the parent Shuttle Stop® cement restrictor that was cleared for marketing by FDA on May 4, 2000 (K000587). Design changes were made to prevent cement leakage and migration, increase pressure resistance, and improve the ease of handling of the cement restrictor. These design modifications are limited to the following: - Adoption of a cylindrical shape for the proposed SynPlug - Elimination of sidewall slots and addition of five flanges - Increase in the rigidity of the proposed device - Expansion of the number of available sizes for the proposed device to 13, designed to fit intramedullary canal diameters of 9 to 21 mm This submission also contains a description of instrumentation sets that have been developed to facilitate the selection of cement restrictor size by assessment of the intramedullary canal diameter and provide correct insertion of the cement restrictor. The SynPlug Instrumentation Set consists of 14 measuring probes for the measurement of canal diameters from 9 to 21 mm, two insertion rods, and a sterilization tray for holding the instruments during sterilization. The Shuttle Stop Instrumentation Set is identical to the SynPlug Instrumentation Set with the exception that only five measuring probes are provided to correspond with the four sizes of Shuttle Stop and a probe measuring the maximum intramedullary canal diameter for which the largest size Shuttle Stop can be used, 8 to 20 mm.